Atlanta Chapter: How Clinical Evaluation Report (CER) Requirements Impact Regulatory and Operational

When:  Mar 14, 2018 from 1:00 PM to 5:00 PM

MED DEV 2.7.1 Rev 4 is in full force. If you haven’t started the process of updating your existing CERs, you are behind the curve. MED DEV 2.7.1 Rev 4 is both more instructive and prescriptive, particularly regarding the use of evidence from equivalent devices.

Please join regulatory professionals from your area to learn about the changes in MED DEV 2.7.1 Rev 4, and how these changes impact your CERs. We will discuss the key changes, additional CER content required for compliance and explore the common mistakes manufacturers make and how to avoid them. We will also discuss how the new EU MDR impacts your CERs. 

Learning Objectives:

  • What is MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU?
  • What are some of the most significant changes?
  • How does it align with the changes to the new EU MDR?
  • In what ways will demonstrating “equivalence” now be harder?
  • How often must you update your CERs now, and what are the qualifications evaluators must have?
  • How should you prepare for the increased notified body scrutiny?
  • How do you perform a clinical literature review to meet the new expectations?
  • Do you need to write a CER for CE Marking? If not, when else do you need to do this and with what focus?

Who Should Attend:

  • Medical device presidents and CEOs
  • Regulatory affairs professionals and management
  • Quality professionals and management
  • Clinical affairs professionals and management 
  • R&D engineers and management

This event, hosted by Arnall Golden Gregory, is brought to you by the RAPS Atlanta Chapter and is intended to facilitate networking among area regulatory personnel. Light refreshments will be provided for all attendees. RAC holders may claim four RAC recertification credits.

Featured Speaker:
Mary Beth Henderson, vice president, regulatory affairs and quality systems, Regulatory and Clinical Research Institute (RCRI)

Registration Information:

Prior to 3 March 2018
RAPS Members: $30
List: $45

On or after 3 March 2018
RAPS Members: $40
List: $55


171 17th St NW Ste 2100
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